Methods and apparatus for endovascularly replacing a heart valve

ABSTRACT

The invention includes methods of and apparatus for endovascularly replacing a heart valve of a patient. One aspect of the invention provides a method including the steps of endovascularly delivering a replacement valve and an expandable anchor to a vicinity of the heart valve in an unexpanded configuration; and applying an external non-hydraulically expanding or non-pneumatically expanding actuation force on the anchor to change the shape of the anchor, such as by applying proximally and/or distally directed force on the anchor using a releasable deployment tool to expand and contract the anchor or parts of the anchor. Another aspect of the invention provides an apparatus including a replacement valve; an anchor; and a deployment tool comprising a plurality of anchor actuation elements adapted to apply a non-hydraulically expanding or non-pneumatically expanding actuation force on the anchor to reshape the anchor.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of application Ser. No. 13/157,733,filed Jun. 10, 2011, which is a continuation of application Ser. No.11/532,019, filed Sep. 14, 2006, which is a continuation of applicationSer. No. 10/982,388, filed Nov. 5, 2004, which is a continuation-in-partof application Ser. No. 10/746,120, filed Dec. 23, 2003, the entiredisclosure of each application being incorporated herein by reference.

BACKGROUND OF THE INVENTION

Heart valve surgery is used to repair or replace diseased heart valves.Valve surgery is an open-heart procedure conducted under generalanesthesia. An incision is made through the patient's sternum(sternotomy), and the patient's heart is stopped while blood flow isrerouted through a heart-lung bypass machine.

Valve replacement may be indicated when there is a narrowing of thenative heart valve, commonly referred to as stenosis, or when the nativevalve leaks or regurgitates. When replacing the valve, the native valveis excised and replaced with either a biologic or a mechanical valve.Mechanical valves require lifelong anticoagulant medication to preventblood clot formation, and clicking of the valve often may be heardthrough the chest. Biologic tissue valves typically do not require suchmedication. Tissue valves may be obtained from cadavers or may beporcine or bovine, and are commonly attached to synthetic rings that aresecured to the patient's heart.

Valve replacement surgery is a highly invasive operation withsignificant concomitant risk. Risks include bleeding, infection, stroke,heart attack, arrhythmia, renal failure, adverse reactions to theanesthesia medications, as well as sudden death. Two to five percent ofpatients die during surgery.

Post-surgery, patients temporarily may be confused due to emboli andother factors associated with the heart-lung machine. The first 2-3 daysfollowing surgery are spent in an intensive care unit where heartfunctions can be closely monitored. The average hospital stay is between1 to 2 weeks, with several more weeks to months required for completerecovery.

In recent years, advancements in minimally invasive surgery andinterventional cardiology have encouraged some investigators to pursuepercutaneous replacement of the aortic heart valve. See, e.g., U.S. Pat.No. 6,168,614. In many of these procedures, the replacement valve isdeployed across the native diseased valve to permanently hold the valveopen, thereby alleviating a need to excise the native valve and toposition the replacement valve in place of the native valve.

In the endovascular aortic valve replacement procedure, accurateplacement of aortic valves relative to coronary ostia and the mitralvalve is critical. Valve anchors comprising standard self-expandingstent systems are expected to have very poor accuracy in deployment,however. In a typical deployment procedure, the proximal end of thestent is not released from the delivery system until accurate placementis verified by fluoroscopy. The stent may jump to another position oncereleased, making it impossible to know where the ends of the stent willbe after release with respect to the native valve, the coronary ostiaand the mitral valve.

Also, visualization of the way the new valve is functioning prior tofinal deployment is very desirable. Due to the expected jumping actionof some self-expanding anchors, and because the replacement valve maynot be fully functional before final deployment, visualization of valvefunction and position prior to final and irreversible deployment may notbe possible with these systems.

Another expected drawback of prior art self-expanding replacement heartvalve systems is their relative lack of radial strength. In order forself-expanding systems to be easily delivered through a delivery sheath,the metal needs to flex and bend inside the delivery catheter withoutbeing plastically deformed. Expandable stent designs suitable forendovascular delivery for other purposes may not have sufficient radialstrength to serve as replacement heart valve anchors. For example, thereare many commercial arterial stent systems that apply adequate radialforce against the artery wall to treat atherosclerosis and that cancollapse to a small enough of a diameter to fit inside a deliverycatheter without plastically deforming. However, when the stent has avalve fastened inside it, and that valve must reside within the heart,as is the case in aortic valve replacement, the anchoring of the stentto vessel walls takes significantly more radial force, especially duringdiastole. The force to hold back arterial pressure and prevent bloodfrom going back inside the ventricle during diastole will be directlytransferred to the stent/vessel wall interface. Therefore, the amount ofradial force required to keep the self-expanding stent/valve in contactwith the vessel wall and not sliding will be much higher than in stentsthat do not have valves inside of them. Moreover, a self-expanding stentwithout sufficient radial force will end up dilating and contractingwith each heartbeat, thereby distorting the valve, affecting itsfunction and possibly causing it to migrate and dislodge completely.Simply increasing strut thickness of the self-expanding stent is not agood solution as it increases profile and/or a risk of plasticdeformation of the self-expanding stent.

In view of drawbacks associated with previously known techniques forendovascularly replacing a heart valve, it would be desirable to providemethods and apparatus that overcome those drawbacks.

SUMMARY OF THE INVENTION

The invention includes methods of and apparatus for endovascularlyreplacing a heart valve of a patient. One aspect of the inventionprovides a method including the steps of endovascularly delivering areplacement valve and an expandable anchor to a vicinity of the heartvalve in an unexpanded configuration; and applying an externalnon-hydraulically expanding or non-pneumatically expanding actuationforce on the anchor through a plurality of anchor actuation elements tochange the shape of the anchor, such as by applying a proximally and/ordistally directed force on the anchor through anchor actuation elementsto change the shape of the anchor. The anchor may be locked in itsexpanded configuration.

Another aspect of the invention provides an apparatus for endovascularlyreplacing a patient's heart valve, including: a replacement valve; ananchor; and a deployment tool comprising a plurality of anchor actuationelements adapted to apply a non-hydraulically expanding ornon-pneumatically expanding actuation force on the anchor to reshape theanchor. An anchor lock may be provided to lock the anchor in a deployedconfiguration, and there may also be a lock prevention elementactuatable from outside the patient. Optionally, the anchor lock may bereversible.

Other aspects of the invention include methods and apparatuses forendovascularly, percutaneously and/or endoscopically delivering anddeploying expandable devices in a patient and optionally detaching adeployment tool from the device.

INCORPORATION BY REFERENCE

All publications and patent applications mentioned in this specificationare herein incorporated by reference to the same extent as if eachindividual publication or patent application was specifically andindividually indicated to be incorporated by reference.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the invention are set forth with particularity inthe appended claims. A better understanding of the features andadvantages of the present invention will be obtained by reference to thefollowing detailed description that sets forth illustrative embodiments,in which the principles of the invention are utilized, and theaccompanying drawings of which:

FIGS. 1A and 1B show replacement valve apparatus in accordance with thepresent invention. FIG. 1 illustrates the apparatus in a collapseddelivery configuration within a delivery system. FIG. 1B illustrates theapparatus in an expanded configuration partially deployed from thedelivery system.

FIGS. 2A-2F show an anchor of the apparatus of FIG. 1 in the collapseddelivery configuration and the expanded deployed configuration, as wellas the full apparatus in the deployed configuration, and optionallocking mechanisms for use with the apparatus.

FIGS. 3A-3E show the use of a replacement heart valve and anchor toreplace an aortic valve.

FIGS. 4A and 4B show an alternative anchor lock embodiment in anunlocked configuration.

FIGS. 5A and 5B show the anchor lock of FIG. 4 in a lockedconfiguration.

FIG. 6 shows an alternative anchor deployment tool attachment andrelease mechanism for use with the invention.

FIG. 7 shows the attachment and release mechanism of FIG. 6 in theprocess of being released.

FIG. 8 shows the attachment and release mechanism of FIGS. 6 and 7 in areleased condition.

FIG. 9 shows an alternative embodiment of a replacement heart valve andanchor and a deployment tool according to the invention in anun-deployed configuration.

FIG. 10 shows the replacement heart valve and anchor of FIG. 9 in apartially deployed configuration.

FIG. 11 shows the replacement heart valve and anchor of FIGS. 9 and 10in a more fully deployed configuration but with the deployment toolstill attached.

FIG. 12 shows yet another embodiment of the delivery and deploymentapparatus of the invention in use with a replacement heart valve andanchor.

FIG. 13 shows the delivery and deployment apparatus of FIG. 12 in theprocess of deploying a replacement heart valve and anchor.

FIG. 14 shows a detail view of a variation of an anchor post.

FIGS. 15A and 15B show an alternative variation of the post having alock alignment feature.

FIGS. 16A and 16B show a variation of the post having an alternativelock alignment feature.

FIG. 17 shows a variation of the post having an expansile element.

FIG. 18 shows a variation of the post with an alternative expansileelement.

FIGS. 19A-19C show a variation of the post having an alternative lockalignment feature.

FIG. 20 shows the post variation of FIG. 14 in combination with anillustrative actuator and release actuator.

FIGS. 21A-21C show a variation of the post, actuator and releaseactuator that form an alternative releasable attachment mechanism.

FIGS. 22A-22C show another variation of the releasable attachmentmechanism.

FIGS. 23A-23C show yet another variation of the releasable attachmentmechanism.

FIGS. 24A and 24B show still another variation of the releasableattachment element.

FIG. 25 shows a variation of the post, actuator and anchor lock elementhaving a reversible lock.

FIGS. 26A-26C show a variation of the actuator, lock actuator andrelease actuator.

FIG. 27 shows a variation of the anchor lock element having a lockalignment feature.

FIGS. 28A and 28B show expansion, locking and actuation of thereleasable attachment mechanism of the apparatus of FIG. 27.

FIG. 29 shows another variation of the apparatus having an actuable lockprevention mechanism.

FIGS. 30A and 30B show a variation of the post that is configured tolock against the braid of the anchor.

FIGS. 31A-31C show actuation and release of a variation of the anchorlock element.

FIGS. 32A and 32B show another variation of a releasable actuationmechanism having a lock alignment mechanism which can be cut from atube.

FIGS. 33A-33D show actuation of a variation of the anchor lock elementthat may be formed from a cut tube.

FIGS. 34A-34F show a variation of the post having an unlock actuator.

FIGS. 35A and 35B show another buckle variation of the anchor lockelement.

FIG. 36 shows attachment of a variation of the anchor lock element tothe anchor.

FIG. 37 shows a variation of the post and anchor lock element having aratcheting lock.

FIGS. 38A and 38B show variations of the ratcheting lock.

FIGS. 39A-39H show actuation of another variation of the ratchetinglock.

FIGS. 40A-40C show a tubular variation of the ratcheting lock element.

FIGS. 41A-41C show a variation of the anchor lock element of FIG. 40.

FIGS. 42A and 42B show a variation of the apparatus of FIG. 41comprising a lock alignment feature.

FIGS. 43A-43F show a method of actuating and adjusting the ratchetinglock of the apparatus of FIG. 41.

FIGS. 44A and 44B show a variation of an anchor/actuator.

FIGS. 45A-45C show detail views of the releasable attachment mechanismof the actuator of FIG. 44.

FIGS. 46A-46C show a variation of the releasable attachment mechanism ofFIG. 45.

FIGS. 47A-47C show another variation of the releasable attachmentmechanism.

FIGS. 48A-48C show yet another variation of the releasable attachmentmechanism.

FIGS. 49A-49N show variations of a release actuator used in conjunctionwith the releasable attachment mechanism of FIG. 45.

FIGS. 50A and 50B show detail views of an embodiment of the deliverysystem/deployment tool.

FIGS. 51A and 51B show the delivery system/deployment tool of FIG. 50releasably attached to apparatus 10, and detached from the apparatus.

FIGS. 52A and 52B show a variation of the delivery system/deploymenttool of FIGS. 50 and 51 wherein the actuators extend from a unitarystructure.

FIGS. 53A-53C show various ways to connect elements to the anchor of thereplacement valve apparatus.

DETAILED DESCRIPTION OF THE INVENTION

The present invention relates to apparatus and methods forendovascularly delivering and deploying a prosthesis, e.g., an aorticprosthesis, within and/or across a patient's native heart valve,referred to hereinafter as replacing the patient's heart valve. Adelivery system and/or deployment tool is provided including a sheathassembly and a guidewire for placing the prosthetic apparatusendovascularly within the patient and a user control allowingmanipulation of the prosthetic apparatus from external to the patientthrough the application of a non-hydraulically expanding ornon-pneumatically expanding force on the anchor. A hydraulically orpneumatically expanding force would be, for example, a force applied tothe anchor by a balloon expanded within the anchor. In certainembodiments, the application of a non-hydraulically expanding ornon-pneumatically expanding force could include the use of a hydrauliccomponent transmitting a proximally or distally directed force on ananchor.

The apparatus includes an anchor and a replacement valve. The anchorincludes an expandable anchor such as a braid. In preferred embodiments,the expandable braid includes closed edges, but the edges mayalternatively be open. The replacement valve is adapted to be securedwithin the anchor, and as such, be delivered endovascularly to thepatient's heart to replace one of the patient's native heart valves.More preferably, the apparatus and methods of the present inventioncontemplate replacement of the patient's aortic valve.

FIGS. 1A and 1B illustrate one embodiment of a deliverysystem/deployment tool and apparatus in accordance with the presentinvention. As seen in FIG. 1A, apparatus 10 may be collapsed fordelivery within delivery system/deployment tool 100. Delivery system 100includes guidewire G, nosecone 102, anchor actuation elements 106,multi-lumen shaft or catheter 108 having optional central lumen 109 anda plurality of circumferentially disposed lumens Lu, external sheath 110having optional proximal handle 111, and control handle 120. Nosecone102 may, for example, be manipulated via a shaft extending throughcentral lumen 109 of multi-lumen catheter 108.

Anchor actuation elements 106 preferably comprise both proximal anchoractuation elements and distal anchor actuation elements. The proximalanchor actuation elements may, for example, comprise actuators 106 athat are releasably coupled to a proximal region of anchor 30 ofapparatus 10 via releasable attachment mechanisms for manipulating aproximal region of apparatus 10. The distal anchor actuation elementsmay comprise actuators 106 b that are releasably coupled to a distalregion of anchor 30 via releasable attachment mechanisms formanipulating the distal region of apparatus 10. In some embodiments, thedistal anchor actuation elements may comprise posts or anchor attachmentelements 32 of anchor 30 and the releasable attachment mechanismsconnecting actuators 106 b to posts 32. In an alternative configuration,the proximal anchor actuation elements may be releasably coupled to aproximal region of apparatus 10 through posts and releasable attachmentmechanisms for manipulation of a proximal region of the apparatus, whilethe distal anchor actuation elements may connect to a distal region ofanchor 30 via releasable attachment mechanisms to manipulate a distalregion of the apparatus. As another alternative, both proximal anddistal anchor actuation element may connect to anchor 30 via releasableattachment mechanisms.

In the embodiment shown in FIG. 1, actuators 106 a may, for example,include stiff finger elements extending from a distal region ofmulti-lumen shaft 108, while actuators 106 b may include control wires(e.g., stands of suture, or metal or polymer wires) which pass throughone or more lumens Lu of shaft 108. Release actuators 112 for thereleasable attachment mechanisms for both sets of actuators also maypass through one or more lumens Lu of shaft 108. The release actuatorsmay comprise, for example, control wires (e.g., strands of suture, ormetal or polymer wires), covers, mandrels, elongated elements, frictionsurfaces, wrap portions, interference shapes, etc. The release actuatorspreferably are movable relative to anchor actuation elements 106, e.g.,via control handle 120.

Control handle 120 is coupled to multi-lumen shaft 108. Knob 122disposed in slot 123 may actuate release actuators 112 that coupleactuators 106 a of anchor actuation elements 106 to apparatus 10.Likewise, knob 124 disposed in slot 125 may actuate release actuators112 that couple actuators 106 b of anchor actuation elements 106 toposts 32 of anchor 30 of apparatus 10. Handle 120 also comprises knob126 for, e.g., manipulating the actuators 106 b to control movement ofthe distal region of apparatus 10 relative to its proximal region.Conversely, controlled movement of the proximal region of apparatus 10relative to its distal region may be achieved by holding knob 126stationary while advancing or retracting handle 120. Knob 126 optionallymay move actuators 106 b in unison with their concomitant releaseactuators 112.

Apparatus 10 comprises anchor 30 and replacement valve 20. Anchor 30preferably comprises a braid. Such braid can have closed ends at eitheror both its ends. Replacement valve 20 is preferably coupled to theanchor along posts 32, e.g., along a valve attachment structure, such asa tab and/or a plurality of holes. Posts 32, therefore, may function asvalve supports and may be adapted to support the replacement valvewithin the anchor. In the embodiment shown, there are three posts,corresponding to the valve's three commissural attachment points. Theposts can be attached to the braid portion of anchor 30. The posts canbe attached to the braid's distal end, as shown in FIG. 2A, centralregion, or proximal end. Replacement valve 20 can be composed of asynthetic material and/or may be derived from animal tissue. Replacementvalve 20 is preferably configured to be secured within anchor 30.

Anchor 30 comprises a plurality of anchor lock elements 34, e.g.,buckles 34, attached to its proximal region, one for each post 32. Posts32 may comprise a lock element that forms a two-part locking mechanismwith anchor lock elements 34 for maintaining anchor 30 in a deployed orexpanded configuration (e.g., as illustrated in FIGS. 1B, 2B and 2C).

In this embodiment, anchor 30 is formed from a collapsible andexpandable wire braid. Anchor braid 30 is preferably self-expanding andis preferably formed from a material such as Nitinol, cobalt-chromiumsteel or stainless steel wire using one or more strands of wire.Delivery and deployment of braided anchor 30 is similar to the deliveryand deployment of the anchors described in U.S. patent application Ser.No. 10/746,120. Specifically, in one embodiment described below, duringdeployment braided anchor 30 is actively foreshortened by proximallyretracting the actuators 106 b relative to the actuators 106 a to expandand lock the anchor in place. In some embodiments, foreshortening mayexpand anchor 30 to a radially symmetrical, bilaterally symmetrical, orasymmetrical expanded shape. The foreshortening step can includeexpanding a first region of the anchor to a first diameter and a secondregion of the anchor to a second diameter larger than the firstdiameter. A third region may also be expanded to a diameter larger thanthe first diameter. The expansion of various regions of the anchor(e.g., the distal region) can be especially useful in locating theaortic valve and centering the anchor within it. Preferably, the securedanchor does not interfere with the mitral valve or the ostia. In someembodiments, the anchor is allowed to self-expand prior to theforeshortening step.

As seen in FIG. 1, after endovascular delivery through sheath 110 to thevicinity of the patient's native valve (such as the aortic valve),apparatus 10 may be expanded from the collapsed delivery configurationof FIG. 1A to the expanded deployed configuration of FIG. 1B usingdelivery system/deployment tool 100. To deploy apparatus 10, externalsheath 110 may be retracted relative to apparatus 10 by proximallyretracting sheath handle 111 relative to control handle 120. Sheath 110is thereby removed from the exterior of apparatus 10, permitting theanchor 30 to self-expand. For example, if anchor braid 30 is composed ofa shape memory material, it may self-expand to or toward its “at-rest”configuration. This at-rest configuration of the braid can be, forexample its expanded configuration, a collapsed configuration, or apartially expanded configuration between the collapsed configuration andthe expanded configuration, or some combination. In preferredembodiments, the anchor's at-rest configuration is between the collapsedconfiguration and the expanded configuration. Depending on the at-restdiameter of the braid and the diameter of the patient's anatomy at thechosen deployment location, the anchor may or may not self-expand tocome into contact with the diameter of the patient's anatomy at thatlocation.

In its collapsed configuration, anchor 30 preferably has a collapseddelivery diameter between about 3 to 30 Fr, or more preferably 6 to 28Fr, or more preferably 12 to 24 Fr. In some embodiments, anchor 30 inits collapsed configuration will have a length ranging from about 5 toabout 170 mm, more preferably from about 10 to about 160 mm, morepreferably from about 15 to about 150 mm, more preferably from about 20to about 140 mm, or more preferably from about 25 mm to about 130 mm.

Similarly, in its expanded configuration, anchor 30 preferable has adiameter ranging between about 10 to about 36 mm, or more preferablyfrom about 24 to about 33 mm, or more preferably from about 24 to about30 mm. In some embodiments, anchor 30 in its expanded configuration willhave a length ranging from about 1 to about 50 mm, more preferably fromabout 2 to about 40 mm, more preferably from about 5 to about 30 mm, ormore preferably from about 7 to about 20 mm.

Overall, the ratio of deployed to collapsed/sheathed lengths ispreferably between about 0.05 and 0.5, more preferably about 0.1 to0.35, or more preferably about 0.15 to 0.25. In any of the embodimentsherein, anchor 30 in its expanded configuration preferably has a radialcrush strength that maintains the anchor substantially un-deformed inresponse to a pressure of up to about 0.5 atm directed substantiallyradially inward toward the central axis, or more preferably up to about2 atm directed substantially radially inward toward the central axis. Inaddition, in any of the embodiments herein, the anchor preferably has anaxial spring constant of between about 10 to 250 g/cm, more preferablybetween about 20 to 200 g/cm, or more preferably between about 40 to 160g/cm. In addition, in any of the embodiments herein, the anchor ispreferably adapted to support the replacement valve at the anchor sitein response to a differential pressure of up to about 120 mm Hg, morepreferably up to about 240 mm Hg, or more preferably up to about 320 mmHg.

These parameters are not intended to be limiting. Additional parameterswithin the scope of the present invention will be apparent to those ofskill in the art.

As seen in FIG. 1B, anchor 30 may be expanded to a fully deployedconfiguration from a partial deployed configuration (e.g., self-expandedconfiguration) by actively foreshortening anchor 30 during endovasculardeployment. In some embodiments, foreshortening of the apparatusinvolves applying a distally directed force on the proximal end of theanchor by one or more anchor actuation elements to move the proximal endof the anchor distally while maintaining the position of the distal endof the anchor. For example, the proximal region of anchor 30 may bepushed distally by certain anchor actuation elements 106, e.g.,actuators 106 a. Alternatively, foreshortening of the apparatus involvesapplying a proximally directed force on the distal end of the anchor byone or more anchor actuation elements to move the distal end of theanchor proximally while maintaining the position of the proximal end ofthe anchor. For example, the distal region of anchor 30 may be pulledproximally via a proximally directed force applied by post actuationelements 106 b, this force opposed by anchor actuators 106 a.

Anchor actuation elements 106 preferably are adapted to expand radiallyas the anchor expands radially and to contract radially as the anchorcontracts radially. Furthermore, proximally or distally directed forcesby the anchor actuation elements on one end of the anchor do notdiametrically constrain the opposite end of the anchor. In addition,when a proximally or distally directed force is applied on the anchor bythe anchor actuation elements, it is preferably applied without passingany portion of a deployment system through a center opening of thereplacement valve. This arrangement enables the replacement valve tooperate during deployment and before removal of the deployment system.

The distal anchor actuation elements may include, for example, actuators106 b and/or release actuators 112 that are controlled, e.g., by controlknobs 124 and 126 of control handle 120. Similarly, the proximal regionsof anchor 30 may be pushed distally via proximal anchor actuationelements, e.g., actuators 106 a, at the proximal region of the anchor.The proximal anchor actuation elements facilitate application of adistally directed force to the proximal end of anchor 30 to move orconstrain the proximal end of the anchor distally and are controlledthrough motion of shaft 108 relative to the distal anchor actuationelements. Control knob 122 of control handle 120 may control releaseactuators 112 for releasing the proximal anchor actuation elements fromthe braid. The proximal anchor actuation elements may be further adaptedto expand as the proximal end of the anchor expands radially duringapplication of a distally directed force on the proximal end of theanchor. Preferably, the proximal anchor actuation elements apply adistally directed force on the proximal end of the anchor system througha plurality of actuators 106 a in order to expand the braid of anchor30. Such braid expansion optionally may be assisted via inflation of aballoon catheter (see FIGS. 12 and 13) reversibly disposed withinapparatus 10, as described in U.S. patent application Ser. No.10/746,120.

In the fully deployed configuration, lock elements of posts 32 andanchor lock elements or buckles 34 of anchor 30 may be used to lock andmaintain the anchor in the deployed configuration. Apparatus 10 may berepositioned or retrieved from the patient until the lock elements ofposts 32 have been interlocked with anchor lock elements 34 of anchor 30to form lock 40. In one embodiment, actuators 106 b and attendantrelease actuators 112 comprise control wires attached to posts 32 thatare threaded through buckles 34 so that the proximally directed forceexerted on posts 32 by the control wires during deployment pulls a lockelement of posts 32 toward and through buckles 34 to form lock 40. Inthis manner, the control wires may act as both anchor actuators and lockactuators.

Such lock optionally may be selectively reversible to allow forrepositioning and/or retrieval of apparatus 10 during orpost-deployment. When the lock is selectively reversible, the apparatusmay be repositioned and/or retrieved as desired, i.e., even afteractuation of lock 40.

Locks used herein may also include a plurality of levels of lockingwherein each level of locking results in a different amount ofexpansion. For example, the anchor lock elements at the proximal end ofthe post can have multiple configurations for locking within the bucklewherein each configuration results in a different amount of anchorexpansion (see, e.g., FIG. 2F). Such locking mechanisms may, forexample, comprise ratchets having multiple lock locations. Furthermore,lock alignment features may be provided to facilitate alignment of thepost and anchor lock elements, such as a hinge or an oversized width ofthe post or anchor lock elements. Furtherstill, lock preventionmechanisms may be provided to preclude locking until desired by amedical practitioner.

When apparatus 10 is placed across a patient's diseased heart valve,anchor 30 may be used to displace the patient's native valve leaflets,and replacement valve 20 will thereafter serve in place of the nativevalve. After final positioning and expansion, apparatus 10 may bedecoupled from delivery system 100 by decoupling the proximal and distalanchor actuation elements 106 from the apparatus via releasableattachment mechanisms, e.g., by decoupling proximal actuators 106 a frombraided anchor 30 and distal actuators 106 b from posts 32 of the anchorvia the releasable attachment mechanisms. Moving release actuators 112,e.g., using knobs 122 and 124 of handle 120, may, for example, actuatethe releasable attachment mechanisms. Preferably, the releasableattachment mechanisms may be actuated by moving the release actuator(s)less than about 1 inch. After decoupling, delivery system/deploymenttool 100 may be removed from the patient, thereby completingendovascular replacement of a patient's heart valve.

Prior to implantation of replacement valve apparatus described herein,it may be desirable to perform a valvuloplasty on the patient's diseasedvalve by inserting a balloon into the valve and expanding it using,e.g., saline mixed with a contrast agent. In addition to preparing thevalve site for implant, fluoroscopic viewing of the valvuloplasty willhelp determine the appropriate size of replacement valve implant to use.

FIGS. 2A-2C show further details of anchor 30 of apparatus 10. FIG. 2Ashows the apparatus in a collapsed configuration, such as for deliverywithin a sheath or other lumen or for retrieval and recapture into asheath or other lumen. FIGS. 2B and 2C show the anchor and valve in anexpanded and locked configuration.

As shown in FIG. 2B, anchor 30 illustratively has three posts and threebuckles. As seen in FIG. 2C, the three leaflets of replacement valve 20may be coupled to the three posts 32 along valve support structures.Thus, posts 32 act as valve supports. The posts, unlike the braid, donot collapse or expand. In some embodiments, a post 32 has one or moreproximal slots 33, at least one proximal hole 36 a and at least onedistal hole 36 b. Leaflet tissue may, for example, be passed throughslot 33 and sutured in place via suture routed through one or moreproximal holes 36 a. In this manner, slot(s) 33 and hole(s) 36 a mayform a valve support structure. Alternative valve support structuresknown in the art for fixing valve leaflets to posts may also beemployed.

Posts 32 may be coupled to anchor braid 30 via one or more distal holes36 b. For example, anchor braid 30 may be woven through holes 36 b, or asuture or wire may be routed through holes 36 b and tied to the braid.Yet another proximal hole (not shown) in post 32 serves as an anchorlock element that interfaces with the anchor lock element provided bybuckle 34 to form lock 40. Buckles 34 may likewise be attached to anchorbraid 30 via weaving or suturing.

Alternative locks may be used to lock the anchor of the presentinvention in the foreshortened configuration, as shown, e.g., in FIGS.2D-2F. Preferably, a lock of the present invention can have multiplelocking options such that locking can confer a plurality of amounts ofexpansion. Furthermore, the locking option can be employedasymmetrically to confer non-cylindrical shapes to the anchor. In FIG.2D, lock 40′ comprises male lock element 44 disposed on post 32 andanchor lock element 34 disposed on braided anchor 30. Anchor lockelement 34 illustratively comprises triangular protrusion or eyelet 42of anchor 30. The triangular shape of female lock element 42 mayfacilitate mating of male lock element 44 with the female lock elementwithout necessitating deformation of the male lock element. One or moreholes 45 may be provided through post 32, e.g., for releasably attachingan actuator 106 b to the post.

In FIG. 2E, lock 40″ comprises alternative male lock element 44′ havingmultiple in-line arrowheads 46 along posts 32. Each arrowhead comprisesresiliently deformable appendages 48 to facilitate passage throughfemale lock element 42′, which illustratively comprises a roundedeyelet. Appendages 48 optionally comprise holes 49, such that releasablelock prevention mechanism 47, illustratively a control wire, may passthrough the holes to constrain the appendages in the deformedconfiguration. To actuate lock 40″, one or more arrowheads 46 of malelock element 44′ are drawn through female lock element 42′, e.g., via apost/lock actuator, and the lock prevention mechanism is removed fromholes 49, thereby causing appendages 48 to resiliently expand andactuate lock 40″.

Advantageously, providing multiple arrowheads 46 along posts 32 yields aratchet that facilitates in-vivo determination of a degree offoreshortening and expansion imposed upon anchor 30. Furthermore,optionally constraining appendages 48 of arrowheads 46 via mechanism 47prevents actuation of lock 40″ (and thereby deployment of apparatus 10)even after male element 44′ has been advanced through female element42′. Only after a medical practitioner has removed lock preventionmechanism 47, which constrains appendages 48, is lock 40″ fully engagedand is deployment no longer reversible.

Lock 40′″ of FIG. 2F is similar to lock 40″ of FIG. 2E, except thatholes 49 on appendages 48 have been eliminated, and the lock preventionmechanism comprises overtube or cover 47. Overtube 47 constrainsappendages 48 to prevent locking until a medical practitioner hasdetermined that apparatus of the present invention has beenforeshortened and positioned adequately at a treatment site. Lock 40′″may, for example, be actuated by applying a proximally-directed force toactuator 106 b. Actuator 106 b illustratively comprises a control wirereleasably disposed through hole 45 in post 32. Lock preventionmechanism 47 then is withdrawn proximally relative to anchor 30, whichcauses the appendages to resiliently expand, thereby fully actuatinglock 40′″.

Referring now to FIG. 3 in conjunction with FIGS. 1 and 2, a method ofendovascularly replacing a patient's diseased aortic valve withapparatus 10 and delivery system/deployment tool 100 is described. Asseen in FIG. 3A, sheath 110 of delivery system 100, having apparatus 10disposed therein, is endovascularly advanced over guidewire G,preferably in a retrograde fashion (although an antegrade or hybridapproach alternatively may be used), through a patient's aorta A to thepatient's diseased aortic valve AV. Nosecone 102 precedes sheath 110 ina known manner. In FIG. 3B, sheath 110 is positioned such that itsdistal region is disposed within left ventricle LV of the patient'sheart H.

Apparatus 10 is deployed from lumen Lu of sheath 110, for example, underfluoroscopic guidance by proximally retracting proximal handle 111 ofsheath 110 relative to shaft 108, such that anchor 30 of apparatus 10dynamically self-expands to the partially deployed configuration of FIG.3C. Advantageously, apparatus 10 may be retracted within lumen Lu ofsheath 110 by retracting shaft 108 relative to the sheath, and therebyretracting actuators 106 a coupled to anchor 30 relative to sheath 110.In this manner, anchor 30 may be retrieved even after the anchor hasdynamically expanded to the partially deployed configuration, forexample, to abort the procedure or to reposition apparatus 10 ordelivery system 100. As yet another advantage, apparatus 10 may bedynamically repositioned, in order to properly align the apparatusrelative to anatomical landmarks, such as the patient's coronary ostiaor the patient's native valve leaflets L. When properly aligned, adistal region of anchor 30 preferably is disposed distal of theleaflets, while a central region of the anchor is disposed across theleaflets and a proximal region is disposed proximal of the leaflets.

Once properly aligned, actuators 106 b are proximally retracted relativeto actuators 106 a, e.g., via knob 126 of handle 120, to imposeforeshortening upon anchor 30 and further expand apparatus 10 to thefully deployed configuration, as in FIG. 3D. Foreshortening increasesthe radial strength of anchor 30 to ensure prolonged patency of valveannulus An, as well as to provide a better seal for apparatus 10 thatreduces paravalvular regurgitation. Lock 40 formed by engaging post lockelements 44 of posts 32 with anchor lock elements 34 of anchor 30maintains imposed foreshortening. Replacement valve 20 is properlyseated within anchor 30, and normal blood flow between left ventricle LVand aorta A is thereafter completely regulated by apparatus 10, althoughvalve 20 is functional during deployment as well. Deployment ofapparatus 10 advantageously is fully reversible until the locks havebeen actuated. Releasable lock prevention mechanisms may be provided toensure that the locks are not actuated prematurely. Furthermore, thelocks may be reversible, such that apparatus 10 may be retrieved orrepositioned even after actuation of the locks.

Once apparatus 10 is fully expanded and locked in the expandedconfiguration, actuators 106 a are decoupled from anchor 30 by actuatingreleasable attachment mechanisms, e.g., by retracting release actuators112 relative to the actuators 106 a via knob 122 of handle 120.Likewise, actuators 106 b are decoupled from posts 32 by actuatingreleasable attachment mechanisms, e.g., by retracting release actuators112 relative to the actuators 106 b via knob 124 of handle 120. As seenin FIG. 3E, delivery system 100 then may be removed from the patient,thereby completing deployment of apparatus 10. Optional barb elements 37engage the patient's native valve leaflets, e.g. to preclude migrationof the apparatus and/or to reduce paravalvular regurgitation.

FIGS. 4 and 5 illustrate anchor lock mechanisms depicted in FIG. 4 inthe locked configuration. FIGS. 4 and 5 should be viewed as ifcylindrical anchor 30 has been cut open and laid flat. Posts 32 coupledto anchor 30 illustratively comprise actuator attachment elements 200and lock elements 202, e.g., eyelets or holes formed through the posts.Anchor 30 comprises anchor lock elements 34, illustratively buckles,which are configured to mate with lock elements 202 of the posts. Posts32 and buckles 34 may, for example, be connected to braided anchor 30 byinter-weaving the posts and the buckles into the braid of the anchor.Alternatively, the posts and/or buckles may be sutured, soldered,welded, connected with adhesive, etc., to the anchor. The commissures ofpreviously described replacement valve 20 may be connected to posts 32along all or a portion of their lengths.

Lock elements 202 of posts 32 mate with tabs 210 extending into holes212 in anchor lock elements 34. To lock, actuators 106 b, whichreleasably pass through actuator attachment elements 200 of posts 32 andholes 212 of anchor lock elements 34, are pulled proximally by anchoractuators 106 b (illustratively control wires) with respect to theproximal end of braided anchor 30 to draw posts 32 through holes 212 sothat tabs 210 engage lock elements 202 of posts 32. Also shown areunlocking actuators 220, illustratively control wires, which passthrough anchor lock eyelets 214 in anchor lock elements 34. If needed,during the procedure, the user may pull on unlocking actuators 220,thereby reversing orientation of tabs 210, releasing the anchor andallowing for repositioning of the device or its removal from thepatient. Only when final positioning as desired by the operatingphysician is achieved, would unlocking actuators 220, as well asactuators 106 b, be removed from apparatus 10 and the patient.

Referring now to FIGS. 6-8, an alternative way of releasing theconnection between the anchor (or post, etc.) and the anchor actuationelements is described. In FIG. 6, release actuator 112, illustratively acontrol wire, extends through actuator 106 a from outside the patient,loops through the proximal region of braided anchor 30 and extendspartially back into actuator 106 a. The doubled up portion of releaseactuator 112 creates a force fit within actuator 106 a that maintainsthe release actuator's position with respect to the actuator 106 a whenall release actuators 112 within actuators 106 a are pulled proximally,e.g., when applying a proximally directed force on anchor 30. When asingle release actuator 112 is pulled proximally, however, thefrictional fit between that release actuator and the actuator 106 a inwhich it is disposed is overcome, enabling the end 113 of releaseactuator 112 to pull free of actuator 106 a, as shown in FIGS. 7 and 8,thereby releasing anchor 30. In an alternative embodiment, the doubledup portion of release actuator 112 may extend proximally to, e.g.,control handle 120. In such an embodiment, expansion of anchor 30 may beachieved by proximally retracting both ends of the doubled up releaseactuator 112 via the control handle, while release of actuator 106 a maybe achieved by pulling on one end of release actuator 112.

FIGS. 9-11 show additional views of apparatus 10. Anchor 30 is made of ametal braid, such as Nitinol or stainless steel. Replacement valve 20 isdisposed within anchor 30. Anchor 30 is actuated in substantially thesame way as described previously through the application of proximallyand distally directed forces from distal anchor actuators (not shown)and actuators 106 a.

FIGS. 12 and 13 show another embodiment of the delivery and deploymentapparatus of the invention. In this embodiment, the nosecone (e.g.,element 102 of FIGS. 1A and 3) is replaced by angioplasty ballooncatheter 230. Thus, angioplasty balloon catheter 230 precedes sheath 110on guidewire G. When anchor 30 and valve 20 are expanded through theoperation of anchor actuation elements 106 as described above, ballooncatheter 230 is retracted proximally within the expanded anchor andvalve and may be inflated to further expand the apparatus 10, asdesired. Optionally, a separate balloon catheter or valvuloplastycatheter may be advanced within apparatus 10 after expansion thereof toachieve additional expansion of the apparatus.

Referring now to FIG. 14, a detail view of a variation of post 32 isdescribed. In FIG. 14, post 32 illustratively comprises actuatorattachment element 250 for attaching the post to an actuator 106 b; postlock element 252, illustratively a slot, for interlocking post 32 withan anchor lock element 34; valve attachment structure 254, comprisingslot 255 and a plurality of holes 256, for attaching replacement valve20 to the post (a tab of the valve may be passed through slot 255, thensewn to the back of the post through holes 256); and braid attachmentelement 258 for attaching the post to a distal region of anchor 30. Thebraid of anchor 30 may, for example, be interwoven through braidattachment element 258. Post 32 may be fabricated from a variety ofmaterials, e.g., metallic materials such as stainless steel, and may belaser cut, die cast, etc. In this variation of post 32, valve 20 isdisposed distal of lock element 252. In alternative variations, thevalve may be attached to the post proximal of the lock element orin-line with the lock element (i.e., neither proximal nor distal to thelock).

FIG. 15 provide an alternative variation of post 32. In FIG. 15, post 32comprises lock element 260 having lock alignment feature 262,illustratively hinge 263. Hinge 263 allows lock element 260 to rotatefrom a position in line with post 32, as in FIG. 15A, to a position outof alignment with the post, as in FIG. 15B, thereby facilitatingalignment with an anchor lock element 34. As shown, post 32 furthercomprises actuator attachment element 264, illustratively an eyelet,valve support structure 266 having slot 267 and a plurality of holes268, and braid attachment element 269.

FIG. 16 illustrate an alternative variation of lock alignment feature262 comprising spring 270. As with hinge 263, spring 270 facilitatesalignment of post lock element 260 with an anchor lock element 34 byallowing the post lock element to rotate from a position in line withpost 32, as in FIG. 16A, to a position out of alignment with the post,as in FIG. 16B. Spring 270 also applies a restoring force that urgespost lock element 260 back into alignment with post 32. Furthermore,spring 270 may facilitate dynamic elongation of post 32 in response toaxial tension. This elongation may facilitate axial lengthening ofanchor 30 in response to radially inward compression applied to theanchor.

With reference to FIG. 17, another variation of post 32 is providedcomprising expansion zone 280, which may, for example, comprise a lasercut feature along post 32. Expansion zone 280 facilitates dynamicelongation of post 32 in response to axial tension applied to the post,which facilitates axial lengthening of anchor 30 in response to radiallyinward compression applied to the anchor. FIG. 18 illustrates analternative expansile element 290 comprising a curved wire or rod thatmay be elongated and straightened through application of axial tensionto facilitate axial lengthening of the anchor in response to radiallyinward compression applied to the anchor (and thereby axial tensionapplied to post 32 via interaction between post lock element 260 and ananchor lock element 34).

Element 290 additionally or alternatively may serve as a lock alignmentfeature. In such a configuration, element 290 optionally may not beexpansile. More generally, post 32 may comprise proximal and distal endsconnected by a tensile member.

FIG. 19 illustrate another variation of post 32 having anotheralternative lock alignment feature 262. In FIG. 19, actuator 106 bapplies a proximally-directed force which brings post lock element 260and anchor lock element 34 proximate to one another allowing the systemto lock. Anchor lock element 34 defines a lock width W₁. In thisembodiment, lock alignment feature 262 comprises post lock element lockarea or width W₂ that is substantially wider than the lock width W₁, forexample, at least about twice as wide. This increased width enhances theprobability of interlocking the post and anchor lock elements, even atsharply misaligned angles. In FIG. 19, post 32 and anchor lock element34 are disposed at an illustrative misalignment angle of about 10°.

Referring now to FIG. 20, the variation of post 32 of FIG. 14 is shownin combination with an illustrative actuator 106 b and release actuator112. In FIG. 20, actuator 106 b illustratively comprises rod 300 havingpost attachment element 302 that mates with actuator attachment element250 of post 32. Angled camming surfaces 304 and 305 of post attachmentelement 302 and actuator attachment element 250, respectively, form aninterface between post attachment element 302 and actuator attachmentelement 250. Proximal movement of actuator 106 b with respect to post 32is translated by the camming surfaces into a lateral force between thetwo elements that acts to separate and release post 32 from actuator 106b. Release actuator 112, illustratively tube 310, may be advanced overactuator 300 to cover the camming surface interface of the post and theactuator 106 b, thereby forming a releasable attachment mechanism forsecuring the post to the actuator even during application of axialtension to the actuator. To separate post 32 from actuator 106 b, e.g.,after expansion and locking of anchor 30, release actuator 112 may beretracted relative to actuator 106 b to the position shown in FIG. 20,thereby removing a constraint from camming surfaces 304 and 305 andallowing the post and actuator to be pulled apart. Release actuator 112preferably is retracted less than about 1 inch relative to the actuator106 b in order to actuate the releasable attachment mechanism, e.g., toremove constraint from camming surfaces 304 and 305.

Referring now to FIG. 21, an alternative releasable attachment mechanismfor attaching a variation of post 32 to a variation of actuator 106 b isdescribed. In FIGS. 21A and 21B, post 32 having actuator attachmentelement 320, illustratively an enlarged proximal opening within thepost, is interference fit with post attachment element 330 of actuator106 b, illustratively an enlarged bulb, knob or other distal protrusionof the actuator. The slope of element 330 provides a camming surfacethat interfaces with an inside surface of opening 320. The angle of thecamming interface between element 330 and opening 320 translatesproximal movement of actuator 106 b with respect to post 32 into alateral movement between actuator 106 b and post 32, thereby separatingthese elements. Release actuator 112, illustratively tube 310, coversthe interference fit releasable attachment mechanism to preclude lateralmovement of the post attachment element relative to the actuatorattachment element, thereby releasably attaching the post to theactuator 106 b. In FIG. 21C, tube 310 is retracted relative to the postand actuator, which permits lateral movement between the post andactuator attachment elements, thereby separating actuator 106 b frompost 32. If tube 310 has not been retracted, of course, proximalmovement of actuator 106 b moves post 32 and the distal portion of theanchor proximally.

FIG. 22 illustrate a variation of the releasable attachment mechanism ofFIG. 21. In the variation of FIG. 22, actuator attachment element 320 ofpost 32 is deformable from a substantially round profile to an oval or“figure eight” profile by advancement of release actuator 112 over theattachment element. This forms a releasable attachment mechanism. In thedeformed profile of FIGS. 22A and 22B, post attachment element 330 ofactuator 106 b is interference fit with the deformed actuator attachmentelement of post 32. In FIG. 22C, retraction of release actuator 112relative to the post and actuator allows actuator attachment element 320to resiliently resume its un-deformed or at-rest configuration, therebypermitting separation of post 32 from actuator 106 b. Actuatorattachment element 320 may, for example, be fabricated from a shapememory material, such as Nitinol. A camming surface 331 on postattachment element 330 and a corresponding surface on the inner portionof element 320 translate proximal movement of actuator 106 b withrespect to post 32 into lateral movement of element 330 with respect toelement 320 when release actuator 112 has been retracted.

In the variation of FIG. 23, post attachment element 330 is deformable(as in FIGS. 23A and 23B), and anchor attachment element 320 may beinterference fit with the post attachment element. FIG. 23C shows thepost attachment element 330 in its at-rest configuration after tube 310has been retracted, thereby releasing anchor attachment element 320. Aswill be apparent, for many or all of the two-part locking or attachmentelement elements described herein, the position of the elements may bereversed.

In FIG. 24, post attachment element 330 comprises wrap portion 332 thatmay be inserted through anchor attachment element 320, illustratively aneyelet, wrapped backwards, then covered with release actuator tube 310to constrain the wrap portion 332 in the wrapped configuration, as inFIG. 24A. Release actuator tube 310 may be retracted relative to thewrap portion to resiliently or dynamically (e.g., by retracting actuator106 b relative to post 32) reshape the wrap portion to a substantiallystraight configuration for releasing the attachment between the post andthe actuator, as in FIG. 24B. Wrap portion 332 preferably is fabricatedfrom a shape memory material, such as Nitinol, or a resilient material,such as spring steel.

FIG. 25 shows another variation of the post, actuator and anchor lockelement. In FIG. 25, post 32 comprises post lock element 260 andactuator attachment element 264, illustratively an eyelet, through whichactuator 106 b is reversibly disposed. Anchor lock element 34illustratively comprises a buckle, which may, for example, be formedfrom a cut tube or a bent resilient material. Anchor lock element 34comprises anchor or braid attachment element 340 for attaching thebuckle to anchor 30, and tab 342 for interlocking the buckle with postlock element 260, which illustratively is a slot formed through post 32.Actuator 106 b therefore actuates the post (and therefore the distal endof the anchor to which the post is attached) as well as the anchor lock.Actuator 106 b may be released from the post (and therefore from theanchor) by pulling one end of the control wire proximally to draw thecontrol wire through and out of opening 264.

Anchor lock element 34 also comprises optional unlock actuatorattachment 344, illustratively a pair of eyelets, through which unlockactuator 350 is releasably coupled to anchor lock element 34. Unlockactuator 350 illustratively comprises a control wire. Upon locking oftab 342 of buckle 34 within slot 260 of post 32, a proximally-directedforce applied to unlock actuator 350 may remove the tab from the slot,thereby unlocking buckle 34 and post 32 and permitting the anchor tocontract and elongate. Unlocking may be utilized, for example, toreposition or retrieve the anchor and valve apparatus even after theapparatus has been locked in the fully deployed configuration, asdescribed previously with respect to FIG. 3.

FIG. 26 show another variation of the actuator, the lock actuator andthe release actuator. As with other anchor lock elements, anchor lockelement 34 in this embodiment is attached to a proximal end of theanchor, and the distal end of post 32 is attached to a distal end of theanchor. The anchor is not shown in FIG. 26 for ease of illustration. Forthe purposes of illustration, the unlock actuator also is not shown inFIG. 26.

As shown, actuator 106 b actuates both post 32 (and therefore the distalend of the anchor to which the post is attached) and the lock formedbetween post lock element 260 and anchor lock element 34. In FIG. 26A,release actuator 112 passes through actuator 106 b to actuate thereleasable attachment mechanism between post 32 and actuator 106 b. FIG.26B provides a detail view of the releasable attachment mechanism.Actuator 106 b comprises wrap portion 360 that passes through actuatorattachment element 264 and wraps around the end of post 32. Wrap portion360 may comprise a shape memory material, such as Nitinol, or adeformable material, e.g., a resiliently deformable material.

Wrap portion 360 further comprises first opening 362 for engagingrelease actuator 112, illustratively a wire or rod that passes throughlumen Lu of actuator 106 b. The walls of the lumen act a linear bearingand/or motion guide during advancement and retraction of the releaseactuator relative to the actuator. Actuator 106 b also comprises secondopening 364, which may be aligned with first opening 362 to engagerelease actuator 112, as shown. As seen in the cross-sectional view ofFIG. 26C, wrap portion 360, and especially the curved portion 361 of thewrap portion, acts as a spring element that urges the first opening outof alignment with the second opening. In this manner, release actuator112 may be interference or friction fit through first opening 362 andsecond opening 364. Retraction of the release actuator proximal of thefirst and second openings may actuate the releasable attachmentmechanism to resiliently or dynamically unwrap portion 360 and releaseactuator 106 b from post 32. Wrap and/or curved portion 360/361 ofactuator 106 b illustratively is disposed at a distal end of theactuator.

As will be apparent to those of skill in the art, the releasableattachment mechanism of FIG. 26 may also be utilized to attach aactuator 106 a to a braided anchor 30. More generally, wrap portion 360provides an illustrative first shape on an anchor actuation element 106that is adapted to mate with a second shape on a post or anchor actuatorattachment element (such as element 264 in FIG. 26, or a wire of thebraid of anchor 30) to substantially prevent relative distal or proximalmovement between the anchor actuation element and the anchor. Theapparatus further comprises a release actuator adapted to actuate thereleasable attachment mechanism. The release actuator is adapted to bemoved to permit relative movement between the first shape and the secondshape. This relative movement may change the first shape and/or thesecond shape to a third shape that permits relative distal or proximalmovement between the anchor actuation element and the anchor or post.Furthermore, this relative movement may separate the anchor actuationelement from the anchor or actuator attachment element.

FIG. 27 illustrates a variation of the anchor lock element of FIG. 26.In FIG. 27, anchor lock element 34 comprises lock alignment feature 370.Feature 370 comprises engagement portion 372, illustratively a loop,that is adapted to engage post 32 before engagement of anchor lockelement 34 (i.e., before engagement of tab 342 of the anchor lockelement) with post lock element 260. Feature 370 ensures alignment ofthe post and buckle prior to locking. Furthermore, feature 370 addsadditional strength to anchor lock element 34 and opposesinwardly-directed forces applied to element 34 when valve 20 ofapparatus 10 closes during diastole.

Referring now to FIG. 28, actuation of the apparatus of FIG. 27 isdescribed. As seen in FIG. 28A, anchor lock element 34 is advanceddistally relative to post 32, for example, by applying adistally-directed force to the anchor via anchor actuator 106 a to movethe proximal portion of the anchor distally while maintaining theposition of post 32 via actuator 106 b. Alternatively or additionally, aproximally-directed force may be applied to post 32 via actuator 106 bwhile maintaining the position of the proximal end of the anchor to movethe distal portion of the anchor proximally. Lock alignment feature 370engages the proximal end of the post prior to interlocking of tab 342 ofanchor lock element 34 with post lock element 260, thereby ensuringproper alignment. Continued retraction of post 32 relative to buckle 34locks the post into the buckle, as shown in FIG. 28B. This also expandsapparatus 10 to the fully deployed configuration of, e.g., FIGS. 1B and2C. Next, release actuator 112 is retracted proximally relative toactuator 106 b, which causes wrap portion 360 of the actuator toresiliently or dynamically swing outwards, thereby bringing firstopening 362 and second opening 364 out of alignment. Proximal retractionof actuator 106 b relative to post 32 removes wrap portion 360 fromactuator attachment element 264 of post 32.

FIG. 29 shows a variation of the apparatus of FIGS. 27 and 28. In FIG.29, anchor lock element 34 comprises locking hoop 380, while post lockelement 260 comprises a wrapped or curved proximal end of post 32. Thecurved proximal end also forms actuator attachment element 264. Wrapportion 360 of actuator 106 b is wrapped about the curved end of post32. Release actuator 112, passing through first opening 362 and secondopening 364 of actuator 106 b, releasably secures this attachment. Therelease actuator further comprises kink 390 that facilitates passage ofthe actuator through release actuator attachment elements 392 of post32, illustratively eyelets. When disposed through elements 392, releaseactuator 112 further acts as a lock prevention mechanism that precludeslocking of the curved proximal end of post 32 with hoop 380 of anchorlock element 34.

In use, the proximal end of post 32 may be retracted-through hoop 380 ofanchor lock element 34. Release actuator 112 then may be retractedrelative to anchor actuator 106 b and post 32, such that the releaseactuator is disposed proximal of attachment elements 392 of the post.Next, post 32 may be allowed to distally advance until its curvedproximal end catches and locks against hoop 380 of element 34. Continuedretraction of release actuator 112 relative to actuator 106 bfacilitates separation of the actuator from the post, as describedpreviously.

Referring now to FIG. 30, an embodiment of post 32 is described that isconfigured to lock against the braid of anchor 30, as opposed to aseparate anchor lock element 34. Post lock element 260 illustrativelycomprises bent tab 400 that catches against the anchor braid to lock theanchor in a deployed configuration.

FIG. 31 illustrate locking and unlocking of a variation of anchor lockelement 34. Anchor lock element 34 of FIG. 31 is similar to the bucklevariation of element 34 described previously with respect to FIGS. 25and 26. However, the variation of FIG. 31 is fabricated from a strip ofmaterial that is bent to form a wrapped or curved portion. FIG. 31Aillustrates the apparatus prior to locking, FIG. 31B illustrates thelocked configuration, and FIG. 31C illustrates unlocking throughapplication of a proximally-directed unlocking force to unlock actuator350.

FIG. 32 show yet another embodiment of a releasable actuation mechanism.Anchor lock element 34 comprises lock alignment mechanism 410 disposedproximal of locking tab 412. As shown, lock alignment mechanism 410engages the distal end of post 32 to align the post and the anchor lockelement prior to locking of post lock element 260 with tab 412 of anchorlock element 34. Lock alignment mechanism 410 adds additional strengthto anchor lock element 34 and opposes inwardly-directed forces appliedto element 34 when valve 20 of apparatus 10 closes during diastole.Advantageously, the inwardly-directed forces act to maintain apparatus10 in the locked configuration. Mechanism 410 optionally may be formedfrom a cut tube.

FIG. 33 illustrate a variation of anchor lock element 34 that may beformed from a cut tube. As seen in FIGS. 33A and 33B, element 34comprises tabs 420 for engaging the curved proximal end of post 32 thatforms post locking element 260. In order to lock the post to element 34,the curved distal end of the post is retracted proximally of tabs 420 bythe action of proximal tension on post 32 by actuator 106 b whileelement 34 is held stationary, as described above. As it enters anchorlock element 34, the curved end of the post is cammed inward by theengagement of the distal edge of element 34 with the outer surface ofthe curved end. Once proximal of tabs 420, the curved end of the postmoves outward, thereby locking the apparatus and preventing subsequentdistal movement of post 32 with respect to element 34. To unlock theapparatus, the curved portion of the post is drawn further proximally byactuator 106 b until the tip of the curved portion moves into an opening422 formed in element 34. As seen in FIGS. 33C and 33D, resilient distaladvancement of the post relative to element 34, e.g., via resilientexpansion of the braid of anchor 30, deforms and straightens the curvedproximal end of post 32 through a camming engagement of the underside ofthe curved portion of the post with the inner surface of opening 422,thereby allowing actuator 106 b to slide off of post 32, unlockingapparatus 10. The curved portion of post 32 optionally may be formedfrom a shape memory material, such that the post resumes its curvedprofile for subsequent relocking after unlocking.

FIG. 34 illustrate a variation of post 32 and anchor lock element 32.Anchor lock element 34 illustratively comprises a curved portion 35 thatengages and enters the slot of post lock element 260 to lock the anchoras post 32 is drawn proximally into element 34 by actuator 106 b. Afterlocking, continued proximal retraction of post 32 by actuator 106 bengages the distal end of the curved portion of element 34 with acamming surface 430 of post 32. Resilient distal advancement of post 32(such as by the resilient contraction and elongation of the anchor toits at-rest configuration) then deforms and straightens the wrapped endof element 34, thereby permitting anchor lock element 34 to separatefrom post 32, unlocking the apparatus.

FIGS. 35 and 36 illustrate additional buckle variations of anchor lockelement 34. Proximal movement of post 32 into anchor lock element 34(by, e.g., actuator 106 b) engages a bottom surface 702 of a curvedportion 700 of element 34 with the proximal end of post 32. Furtherproximal movement of post 32 with respect to element 34 cams curvedportion 700 forward until the curved end 704 of curved portion 700 meetsand resiliently moves into opening 260 in post 32, locking theapparatus. The variation of FIG. 36 illustrates attachment to the braidof anchor 30 via sutures or the like passed through openings 340 inelement 34. The lock is unlockable via unlock actuator 350.

Referring now to FIG. 37, an embodiment of a post 32 and anchor lockelement 34 with a ratcheting lock is described. Post 32 comprisespreviously described actuator attachment element 250 that is releasablysecured to post attachment element 302 of actuator 106 b. (Otherreleasable attachment mechanisms may alternatively be used.) Post 32also comprises braid attachment element 430 and valve attachmentstructure 432. In the variation of FIG. 37, valve attachment structure432 comprises tab 433 that extends from post 32, as well as a pluralityof holes 434 through post 32 and a plurality of holes 435 through tab433. Replacement valve 20 may be attached to post 32 by sewing the valveto the valve attachment structure through holes 434 and/or 435.

Post 32 further comprises ratcheting locking element 440 having aplurality of inclined planes with camming surfaces 442 and frictionsurfaces 443. The inclined planes are disposed along either side of tab433 for ratcheting and locking against ratcheting anchor lock element34. Anchor lock element 34 comprises ratchet teeth 450 on either side ofthe valve attachment elements that cam against surface 442 and lockagainst friction surfaces 443 of element 440 of post 32, as post 32 isproximally retracted through element 34. Advantageously, providingmultiple rows of inclined plane ratchets along post 32 facilitatesinterlocking of the post and the element at multiple discrete locations.

Element 34 comprises proximal and distal slots 452 that receive post 32,as well as central longitudinal slot 453 that facilitate passage of tab433 (and thereby valve 20) therethrough. Actuator 106 b may be disposedthrough slots 452 prior to approximation and locking of the post toanchor lock element 34 in order to facilitate alignment of the post andthe anchor lock element. Element 34 may be ratcheted to any positionalong ratchet lock element 440 to achieve any desired lockingconfiguration and degree of expansion of apparatus 10. Valve attachmentstructure 432, and thereby replacement valve 20, may be positionedproximal of the ratchet lock post-deployment or in line with the ratchetlock (i.e., neither proximal nor distal to the ratchet lock). Element 34further comprises unlock actuator attachment(s) 454 for coupling theelement to an unlock actuator, e.g., previously described unlockactuator 350, to unlock element 34 by applying a proximally-directedunlocking force that displaces ratchet teeth 450 from friction surfaces443.

FIG. 38 illustrate variations of the apparatus of FIG. 37. Ratchet lockelements 440 of posts 32 in FIG. 38 comprise a plurality of ratchetslots 444 in which ratchet tooth 450 of anchor lock element 34 may belocked. Ratchet tooth 450 comprises proximal friction surface 456 anddistal camming surface 457 to facilitate proximal retraction of a post32 through slot 452 for ratcheting of camming surface 457 throughratchet slots 444, but to preclude distal advancement of the post onceratchet tooth 450 is engaged within ratchet slots 444 by locking aratchet slot against friction surface 456. As with the variation of FIG.37, anchor lock element 34 is unlockable and comprises unlock actuatorattachment 454. In contrast to the variation of FIG. 37, the ratchetlock is disposed proximally of valve attachment structure 432, andthereby proximally of replacement valve 20. In FIG. 38A, valveattachment structure 432 comprises slot 436 instead of tab 433.

FIG. 39 illustrate another variation of the ratchet lock of FIG. 37. InFIG. 39, ratchet lock elements 440 of post 32 extend along only one edgeof the post. Thus, anchor lock element 34 comprises unitary ratchettooth 450 for camming against surfaces 442 and locking against frictionsurfaces 443 of elements 440 of post 32, as post 32 is proximallyretracted through element 34.

The apparatus of FIG. 39 also comprises unlock or adjustment actuator500 that is releasably attached to anchor lock element 34 along unlockactuator attachment 454. Actuator 500 comprises two independently orconcurrently actuable elements: adjustment element 510 and releaseelement 520. Adjustment element 510 comprises elongated member 512having protrusion 514 with lumen 515, as well as distal extension 516with notch 518 having optional camming surface 519. Release element 520comprises elongated member 521, which may, for example, comprise amandrel, that is configured for passage through lumen 515 of protrusion514 of adjustment element 510. Elongated members 512 and 521 of actuator500 preferably extend through delivery system 100 to the exterior of thepatient for independent or concurrent advancement and/or retraction by amedical practitioner.

As seen in FIG. 39A, notch 518 of adjustment element 510 of actuator 500may be positioned within unlock actuator attachment 454 of anchor lockelement 34 during deployment of apparatus 10. As seen in FIG. 39B,anchor lock element 34 is locked within ratcheting lock elements 440 ofpost 32 by proximally retracting actuator 106 b relative to anchor lockelement 34. Release element 520 then may be advanced relative toadjustment element 510 to position elongated member 521 within unlockactuator attachment 454 adjacent distal extension 516 of adjustmentelement 510. This serves to friction lock or interference fit actuator500 within attachment 454 along notch 518 of adjustment element 510.Thus, concurrent advancement and/or retraction of the adjustment andrelease elements of actuator 500 by a medical practitioner causes anchorlock element 34 to move in unison with actuator 500. As will beapparent, actuator 500 alternatively may be friction locked with anchorlock element 34 prior to full deployment of apparatus 10. Furthermore,actuator(s) 500 may assist, or be used in place of, actuators 106 a todeploy apparatus 10.

As seen in FIG. 39C, the lock formed between anchor lock element 34 andpost 32 may be unlocked or adjusted, as desired, by applying a lateralunlocking force to ratchet tooth 450 via actuator 500 that pulls theratchet tooth away from a friction surface 443 of ratcheting lockelements 440. Actuator 500 then may be distally advanced or, as seen inFIG. 39D, proximally retracted relative to ratcheting lock elements 440and post 32 to further expand or partially collapse anchor 30,respectively (further expansion alternatively may be achieved by furtherratcheting ratchet tooth 450 along camming surface 442 of ratchetinglock elements 440, e.g., by further proximally retracting actuator 106b, which is not shown in FIGS. 39C-39F for the sake of clarity). Anchoractuation elements 106 may assist such controlled expansion or collapseanchor 30.

When (re-)positioned at a desired location and/or when a desired degreeof locking has been achieved, the lateral unlocking force may be removedfrom ratchet tooth 450 to again lock anchor lock element 34 to post 32along ratcheting lock elements 440, as in FIG. 39E. To completedeployment of apparatus 10, adjustment actuator 500 and actuator 106 b,as well as actuator 106 a (not shown), may be separated from theapparatus. In FIG. 39F, release element 520 of actuator 500 isproximally retracted relative to adjustment element 510, therebyremoving elongated member 521 of release element 520 from unlockactuator attachment 454 of anchor lock element 34. This removes theinterference fit between notch 518 and attachment 454. Proximalretraction of actuator 500 relative to anchor lock element 34 detachesadjustment element 510 of actuator 500 from attachment 454 of anchorlock element 34, as in FIG. 39G. Optional camming surface 519 alongnotch 518 may facilitate such detachment. In FIG. 39H, actuator 106 b isdetached from post 32 by retracting release actuator 112 relative to theactuator, as described previously.

Referring now to FIG. 40, another variation of an adjustable ratchetinglock element is described. As seen in FIG. 40A, post 32 comprises tube470 having lumen 471 and ratcheting lock element 472, illustratively aplurality of slots that communicate with lumen 471. Post 32 alsocomprises valve support structure or attachment element 474 and braidattachment element 476.

Anchor lock element 34, which may be fabricated from a cut tube,comprises a substantially cylindrical structure having braid attachmentelement 480, lumen 482 and tabs 484. As seen in the top view of FIG.40B, tabs 484 of anchor lock element 34 are configured for lockingwithin the slots of ratcheting lock element 472 of post 32. As seen inthe top view of FIG. 40C, adjustment actuator 490, illustrativelymandrel M having tapered distal end 494 that acts as a camming surface,may be advanced through lumen 481 of anchor lock element 34 and lumen471 of tube 470 of post 32, to displace tabs 484 from the locking slotsof post 32, thereby unlocking the post from the anchor lock element.This facilitates, for example, readjustment of a degree oflocking/expansion of apparatus 10, repositioning of apparatus 10,retrieval of apparatus 10, etc.

FIG. 41 illustrate a variation of anchor lock element 34 wherein tabs484 are positioned along a different axis. This may provide a moresecure lock between post 32 and anchor lock element 34. FIG. 42illustrate a variation of post 32 configured for use with the variationof anchor lock element 34. In FIG. 32, post 32 comprises groove 478 thatconnects the slots of ratcheting lock element 472. Groove 478 does notcommunicate with lumen 471 of tube 470 of post 32. Rather, the groovemay act as a lock alignment mechanism that guides tabs 484 of anchorlock element 34 along post 32 and ratcheting lock element 472, as seenin the top view of FIG. 42B.

Referring now to FIG. 43, a method of actuating the variation of FIG. 41is described. As seen in FIG. 43A, adjustment actuator 490 is initiallydisposed through lumen 482 of anchor lock element 34 and within lumen471 of post 32. Post 32 then may be proximally retracted relative toanchor lock element 34, e.g., via actuator 106 b (not shown). In FIG.43B, actuator 490 serves as a lock prevention mechanism that precludeslocking of tabs 484 within ratcheting lock element 472. In FIG. 43C,actuator 490 is retracted relative to post 32 and anchor lock element34, which opens up lumen 471 of tube 470 and allows tabs 484 to passthrough the slots of ratcheting lock element 472, thereby locking thepost to the anchor lock element. In FIG. 43D, actuator 490 isre-advanced within lumen 471, such that tapered distal end 494 ofmandrel M serves as a camming surface that urges tabs 484 out of lumen471 as the actuator is advanced. This unlocks the post from the anchorlock element to facilitate adjustment, repositioning or retrieval ofapparatus 10. In FIG. 43E, a degree of locking/expansion of theapparatus is adjusted by repositioning anchor lock element 34 relativeto post 32, and thereby tabs 484 relative to ratcheting lock element472. When properly adjusted, actuator 490 may be removed from lumen 471of tube 470 of post 32, as in FIG. 43F. Tabs 484 resiliently return tothe locked configuration within the slots of ratcheting lock element472.

Referring now to FIG. 44, an embodiment of anchor/actuator 106 a isdescribed. Actuator 106 a comprises elongated member 600 having proximalextension 602 that may be attached, for example, to previously describedmulti-lumen shaft or catheter 108 of delivery system/deployment tool 100(see FIG. 1), e.g., via epoxy, UV curing, etc. Lumen 601 extends throughelongated member 600 from proximal extension 602 to releasableattachment mechanism 604. Releasable attachment mechanism 604 releasablyattached actuator 106 a to the braid of anchor 30. The mechanismcomprises release actuator 112 and illustratively is similar to thepreviously described releasable attachment mechanism of FIGS. 26-28.Release actuator 112, illustratively a mandrel, passes through a lumenLu of multi-lumen shaft 108 and then through lumen 601 of actuator 106 ato mechanism 604.

Actuator 106 a further comprises shaping features 606 that affect ashape of the anchor actuator when an anchor actuation force is appliedto anchor 30. These features may comprise, for example, reduced diameterportions of the actuator, reduced wall thickness portions of theactuator and/or slits formed in the anchor actuator. Application of ananchor actuation force may, for example, provide actuator 106 a with theprofile seen in FIG. 44A. This profile may facilitate expansion ofanchor 30/apparatus 10. As will be apparent, shaping features may beprovided with any anchor actuation elements 106, including any of thepreviously described variations of actuators 106 b.

As seen in FIG. 45, releasable attachment mechanism 604 comprises wrapportion 610 that may, for example, pass through the braid of anchor 30and wrap around the proximal end of the anchor. Wrap portion 610 maycomprise a shape memory material, such as Nitinol, or a deformablematerial, e.g., a resiliently deformable material. The wrap portioncomprises first opening 612 for engaging release actuator 112. The wallsof lumen 601 of elongated member 600 may act as a linear bearing and/ormotion guide during advancement and retraction of the release actuatorrelative to the actuator. Actuator 106 a also comprises second opening614, which may be aligned with first opening 612 to engage releaseactuator 112, as shown. Wrap portion 610, and especially curved portion611 of the wrap portion, acts as a spring element that urges the firstopening out of alignment with the second opening to engage and holdrelease actuator 112 in place.

As seen in FIG. 45C, when the release actuator is retracted proximallyrelative to the actuator, wrap portion 610 resiliently or dynamicallyswings outwards. Thereafter, proximal retraction of anchor actuator 106a relative to anchor 30 detaches wrap portion 610, and thereby actuator106 a, from the anchor. Surface 616 of wrap portion 610 may act as acamming surface as the inner surface of wrap portion 610 slides alongthe anchor braid 30 to facilitate such detachment.

In this manner, release actuator 112 may be interference or friction fitthrough first opening 612 and second opening 614. Retraction of therelease actuator proximal of the first and second openings actuatesreleasable attachment mechanism 604 to resiliently or dynamically unwrapportion 610 and release actuator 106 a from anchor 30. Wrap portion 610of actuator 106 a illustratively is disposed at a distal end of theactuator.

With reference to FIG. 46, a variation of releasable attachmentmechanism 604 is described. In FIG. 46, wrap portion 610 illustrativelycomprises tabs 618 that act as an alignment mechanism for aligning thewrap portion of mechanism 604 with elongated member 600. This mayfacilitate advancement of release actuator 112 through mechanism 604.FIG. 47 illustrate a variation of tabs 618 wherein the tabs are rounded.This may reduce friction, provide an atraumatic surface, etc. Additionalshapes for tabs 618 will be apparent. Alternatively, tabs 618 may act asspring elements which are loaded when element 630 is seated, as shown inFIG. 47B. In this configuration tabs 618 apply a force directed towardselement 630 such that 630 will be ejected when element 112 is retracted.In this way tabs 618 apply a restraining force on element 112 whichreduces the risk of an early release.

FIG. 48 illustrate a variation of wrap portion 610 that comprises asubstantially straight distal region in an at-rest configuration, asseen in FIG. 48C. It is expected that providing a substantially straightdistal region along wrap portion 610 may facilitate detachment ofactuator 106 a from anchor 30, i.e., may reduce a risk of snagging thewrap portion along the braid of the anchor. The wrap portion may beresiliently deformed for passage, of release actuator 112 through firstopening 612, as in FIGS. 48A and 48B.

Referring now to FIG. 49, variations of release actuator 112 for usewith releasable attachment mechanism 604 are described. In FIG. 49A, therelease actuator comprises a simple mandrel. In FIGS. 49B and 49C, therelease actuator comprises protrusion 620 having friction surface 621.In FIG. 49D, actuator 112 comprises coil 622. In FIGS. 49E-49H, theactuator comprises kink 624, which may act as a camming surface, asshown. The kink may also provide tactile feedback to a medicalpractitioner. In FIGS. 491 and 49J, the release actuator comprises ballor knob 626 disposed proximal of the actuator's distal end. In FIGS. 49Kand 49L, ball 626 is disposed at the distal end of actuator 112. Theball may act as a camming surface. In FIG. 49M, actuator 112 comprisesprotrusion 628 having proximal camming surface 629. In FIG. 49N, theactuator comprises oblong protrusion 430 having friction surface 431.Additional variations of actuator 112 will be apparent.

Referring now to FIG. 50, an embodiment of delivery system/deploymenttool 100 is described. FIG. 50A provides a detail view of multi-lumencatheter 108 and sheath 110. As discussed previously catheter 108comprises central lumen 109 and a plurality ofcircumferentially-disposed lumens Lu.

As seen in FIG. 50B, actuator 106 a is coupled to catheter 108 viaproximal extension 602, such that lumen 601 is coaxially disposed withina lumen Lu of the catheter. Release actuator 112 extends through lumensLu and 601. Actuator 106 a is distally attached to the braid of anchor30 along releasable attachment mechanism 604. For the sake of clarity, asingle actuator 106 a is shown in FIG. 50B, but multiple such actuatorspreferably are provided, as in FIG. 51 described hereinafter.

FIG. 50B also illustrates actuator 106 b. The actuator extends through alumen Lu of catheter 108 and through anchor lock element 34 to post 32(not shown). Unlock actuator 350 is also provided and extends through alumen Lu to unlock actuator attachment 344 of anchor lock element 34.Anchor lock element 34 illustratively comprises the variation describedpreviously with respect to FIG. 31. The element is attached to the braidof anchor 30 along anchor attachment elements 340. As with actuator 106a, a single anchor lock element 34 and actuator 106 b are shown in FIG.50B. This is only for the sake of clarity, and multiple such actuatorsmay be provided, e.g., three actuators.

Referring now to FIG. 51, delivery system/deployment tool 100 is shownwith a plurality of actuators 106 a and actuators 106 b for releasableattachment to anchor 30 of apparatus 10. In FIG. 51A, anchor actuationelements 106 a are coupled to the anchor. In FIG. 51B, the elements aredecoupled from the anchor.

With reference now to FIG. 52, a variation of the deliverysystem/deployment tool of FIGS. 50 and 51 is described comprising aplurality of arms or actuators that extend from a unitary structure.Unitary structure 650, which may extend from a distal region ofmulti-lumen shaft 108, is preferably fabricated from a laser-cut tube.Structure 650 comprises a plurality of circumferentially disposed arms652 that serve as actuators. Expansile elements 654 may be disposedbetween arms 652 and facilitate constraint of the arms radially outwardor inward with respect to other arms as the anchor reshapes. FIG. 52Ashows the arms in a radially collapsed configuration, and FIG. 52B showsthe arms in a radially expanded configuration. Wrap portions 655 areadapted to wrap around the proximal portion of an anchor braid. Openings656 and 657 are formed in wrap portions 655 to engage a releaseactuator, as described in embodiments above.

Referring now to FIG. 53, various ways to connect elements to the braidof anchor 30 of replacement valve apparatus 10 are described. In FIG.53A, a post 32 having a single braid attachment hole 660 is attached toanchor 30 along three separate intersections of the braid via suture S.FIG. 53B provides a detail view of one exemplary technique for routingthe suture between hole 660 and anchor 30. FIG. 53C illustrates avariation of the attachment, wherein post 32 comprises multiple braidattachment holes 660. As will be apparent, elements other than posts 32may be attached to anchor 30 in the manner described, for example,anchor lock elements 34 may be attached in a similar manner.

While preferred embodiments of the present invention are shown anddescribed herein, it will be obvious to those skilled in the art thatsuch embodiments are provided by way of example only. Numerousvariations, changes, and substitutions will occur to those skilled inthe art without departing from the invention. For example, while theinvention was described in connection with the replacement of a naturalvalve, the invention may also be used to replace an earlier-implantedprosthetic valve. Also, while the preceding discussion described the useof the invention to deliver and deploy replacement heart valves, itshould be understood that the invention is not limited to thatparticular use. Other aspects of the invention include methods andapparatuses for endovascularly, percutaneously and/or endoscopicallydelivering and deploying expandable devices in a patient and optionallydetaching a deployment tool from the device.

It should be understood that various alternatives to the embodiments ofthe invention described herein may be employed in practicing theinvention. It is intended that the following claims define the scope ofthe invention and that methods and structures within the scope of theseclaims and their equivalents be covered thereby.

1. A catheter assembly for endovascularly delivering a heart valve, thecatheter assembly comprising: an outer delivery sheath; an implantablereplacement valve disposed within the delivery sheath, the valvecomprising an expandable anchor configured to be implantable within apatient, the anchor comprising a distal end and a proximal end; and adeployment tool comprising a first plurality of anchor actuationelements coupled to the distal end or the proximal end of the anchor andadapted to apply a non-hydraulically expanding or non-pneumaticallyexpanding actuation force on the anchor to reshape the anchor.
 2. Thesystem of claim 1 wherein the first plurality of actuation elements arecoupled to the proximal end of the anchor.
 3. The system of claim 2wherein the first plurality of actuation elements are coupled to theproximal end of the anchor via releasable attachment mechanisms.
 4. Thesystem of claim 2 further comprising a second plurality of actuationelements coupled to the distal end of the anchor.
 5. The system of claim4 wherein the second plurality of actuation elements are coupled to thedistal end of the anchor via releaseable attachment mechanisms.
 6. Thesystem of claim 1 further comprising a control handle coupled to aninner multi-lumen catheter shaft comprising, the control handle iscoupled to first release actuators coupled to the first plurality ofactuation elements.
 7. The system of claim 6 wherein the control handlecomprises a first slot and a first knob disposed within the first slotfor manipulating the first plurality of actuation elements.
 8. Thesystem of claim 7 wherein the first release actuators are movablerelative to the anchor actuation elements via the control handle.
 9. Thesystem of claim 6 wherein the control handle is coupled second releaseactuators coupled to the second plurality of actuation elements.
 10. Thesystem of claim 9 wherein the control handle comprises a second slot anda second knob disposed within the slot for manipulating a secondplurality of actuation elements coupled to the distal end of the anchor,the first plurality of actuation elements, wherein the first pluralityof actuation elements and the second plurality of actuation elementspass through one or more lumens of the multi-lumen shaft.
 11. The systemof claim 10 wherein the second release actuators are movable relative tothe second plurality of actuation elements via the control handle.